Delivery catheter for endovascular device

ABSTRACT

Some embodiments relate in part to endovascular prostheses and delivery catheter systems and methods for deploying same. Embodiments may be directed more specifically to graft bodies having self-expanding members, including inflatable graft bodies, and catheters and methods for deploying same within the body of a patient.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/835,491, filed Mar. 15, 2013, by J. Watson et al., titled DeliveryCatheter for Endovascular Device, which claims priority under 35 U.S.C.119(e) from U.S. Provisional Patent Application No. 61/621,286, filedApr. 6, 2012, by J. Watson et al., titled Delivery Catheter forEndovascular Device, both of which are incorporated by reference hereinin their entirety.

FIELD OF THE INVENTION

Some embodiments relate in part to endovascular prostheses and methodsof deploying same. Embodiments may be directed more specifically tostent grafts and methods of making and deploying same within the body ofa patient.

BACKGROUND

An aneurysm is a medical condition indicated generally by an expansionand weakening of the wall of an artery of a patient. Aneurysms candevelop at various sites within a patient's body. Thoracic aorticaneurysms (TAAs) or abdominal aortic aneurysms (AAAs) are manifested byan expansion and weakening of the aorta which is a serious and lifethreatening condition for which intervention is generally indicated.Existing methods of treating aneurysms include invasive surgicalprocedures with graft replacement of the affected vessel or body lumenor reinforcement of the vessel with a graft.

Surgical procedures to treat aortic aneurysms can have relatively highmorbidity and mortality rates due to the risk factors inherent tosurgical repair of this disease as well as long hospital stays andpainful recoveries. This is especially true for surgical repair of TAAs,which is generally regarded as involving higher risk and more difficultywhen compared to surgical repair of AAAs. An example of a surgicalprocedure involving repair of an AAA is described in a book titledSurgical Treatment of Aortic Aneurysms by Denton A. Cooley, M.D.,published in 1986 by W. B. Saunders Company.

Due to the inherent risks and complexities of surgical repair of aorticaneurysms, endovascular repair has become a widely-used alternativetherapy, most notably in treating AAAs. Early work in this field isexemplified by Lawrence, Jr. et al. in “Percutaneous Endovascular Graft:Experimental Evaluation”, Radiology (May 1987) and by Mirich et al. in“Percutaneously Placed Endovascular Grafts for Aortic Aneurysms:Feasibility Study,” Radiology (March 1989). Commercially availableendoprostheses for the endovascular treatment of AAAs include theAneuRx® stent graft manufactured by Medtronic, Inc. of Minneapolis,Minn., the Zenith® stent graft system sold by Cook, Inc. of Bloomington,Ind., the PowerLink® stent-graft system manufactured by Endologix, Inc.of Irvine, Calif., and the Excluder® stent graft system manufactured byW.L. Gore & Associates, Inc. of Newark, Del. A commercially availablestent graft for the treatment of TAAs is the TAG™ system manufactured byW.L. Gore & Associates, Inc.

When deploying devices by catheter or other suitable instrument, it isadvantageous to have a flexible and low profile stent graft and deliverysystem for passage through the various guiding catheters as well as thepatient's sometimes tortuous anatomy. Many of the existing endovasculardevices and methods for treatment of aneurysms, while representingsignificant advancement over previous devices and methods, use systemshaving relatively large transverse profiles, often up to 24 French.Also, such existing systems have greater than desired lateral stiffness,which can complicate the delivery process. In addition, the sizing ofstent grafts may be important to achieve a favorable clinical result. Inorder to properly size a stent graft, the treating facility typicallymust maintain a large and expensive inventory of stent grafts in orderto accommodate the varied sizes of patient vessels due to varied patientsizes and vessel morphologies. Alternatively, intervention may bedelayed while awaiting custom size stent grafts to be manufactured andsent to the treating facility. As such, minimally invasive endovasculartreatment of aneurysms is not available for many patients that wouldbenefit from such a procedure and can be more difficult to carry out forthose patients for whom the procedure is indicated.

What have been needed are stent graft systems and methods that areadaptable to a wide range of patient anatomies and that can be safelyand reliably deployed using a flexible low profile system.

SUMMARY

Some embodiments are directed to a delivery system for an inflatableendoluminal prosthesis having a delivery catheter. In some embodiments,the delivery catheter may have an elongate shaft including a proximalsection and a fill tube including a fill tube lumen extending axiallywithin the fill tube. In some cases, the endoluminal prosthesis may bereleasably secured to the proximal section of the delivery catheter. Theendoluminal prosthesis may include an inflatable portion with aninterior volume in fluid communication with an inflation port which maybe releasably coupled to a proximal end of the fill tube. In someembodiments, a fill tube retention mechanism may releasably secure thefill tube lumen of the fill tube in fluid communication with theinflation port. The fill tube retention mechanism may have a tab whichis disposed at a distal end of the endoluminal prosthesis insubstantially fixed relation to the inflation port and which may includean aperture in the tab which is separated from the inflation port by apredetermined distance in some embodiments. In some embodiments, afitting may be secured to a proximal portion of the fill tube of thedelivery catheter which may extend laterally from the fill tube andwhich may include at least a portion that is sized to pass through theaperture in the tab. In some instances, the tab may be disposed adistance from a proximal end of the fill tube which allows the fill tubeto be engaged with the inflation port while the fitting may be disposedwithin the aperture in the tab. A fitting may include a passage throughthe fitting in some embodiments. In some cases, a release wire having anouter transverse dimension and axial bending stiffness that allows therelease wire to pass through the passage of the fitting may assist inmechanically capturing the tab to the fitting. The tab may be disposedbetween the release wire and the fill tube with the release wiredisposed in the passage in some embodiments. In some cases, the tabincludes PTFE material.

Some embodiments of the delivery catheter for delivery of an inflatableendoluminal prosthesis may include an elongate shaft having a proximalsection and a fill tube. In some cases, the fill tube may include a filltube lumen in fluid communication with a distal section of the elongateshaft and extending axially therein. In addition, a fitting may besecured to a proximal portion of the fill tube of the delivery catheterwhich may extend laterally from the fill tube and which may include atleast a portion that may be sized to pass through an aperture in a tabof an endoluminal prosthesis in some embodiments. In some cases, the tabmay be disposed a distance from a proximal end of the fill tube whichmay be configured to allow the fill tube to be engaged with an inflationport of an inflatable endoluminal prosthesis. The fitting may have apassage through the fitting in some embodiments. In some cases, arelease wire including an outer transverse dimension and axial bendingstiffness that allows the release wire to pass through the passage ofthe fitting may mechanically capture a tab of an endoluminal prosthesisto the fitting. The tab may be disposed between the release wire and thefill tube with the release wire disposed in the passage in someembodiments. In some cases, the passage of the fitting includes an axialpassage which is substantially parallel to the lumen of the fill tube.In some instances, the release wire extends from the fitting to a distalend of the catheter and is coupled to a release mechanism which isdisposed at a distal end of the delivery catheter and which isconfigured to apply axial tension and displacement to the release wirein order to axially retract the release wire and release the fittingfrom an aperture of a tab of an endoluminal prosthesis. For someembodiments, the fill tube may include a plurality of fittings, aplurality of release wires, a transverse dimension of about 1 mm toabout 2 mm or both. In some cases, an outer transverse dimension of thefill tube may be configured to slide within an inner lumen of aninflation port of an endoluminal prosthesis and provide a sealtherebetween for viscous fluids.

Some embodiments are directed to a method of releasably securing a filltube of a delivery catheter to an inflation port of an inflatableportion of an inflatable endoluminal prosthesis. The method may includedelivering an endoluminal prosthesis to a treatment site with theendoluminal prosthesis being releasably secured to a proximal section ofa delivery catheter. In some embodiments, the endoluminal prosthesis mayinclude an inflatable portion with an interior volume in fluidcommunication with an inflation port. A proximal end of a fill tube ofthe delivery catheter may be releasably coupled to the inflation portwith a fill tube retention mechanism that releasably secures the filltube lumen of the fill tube in fluid communication with the inflationport in some embodiments. In some cases, the fitting may be releasedfrom the tab by retracting the release wire from the passage such thatthe tab may be no longer mechanically captured over the fitting betweenthe fill tube and the release wire. The fill tube retention mechanismmay include a flexible tab disposed at a distal end of the endoluminalprosthesis in fixed relation to the inflation port and may include anaperture in the tab which may be separated from the inflation port by apredetermined distance in some embodiments. In some cases, the fill tuberetention mechanism may further include a fitting secured to a proximalportion of the fill tube of the delivery catheter which may extendlaterally from the fill tube and include at least a portion that may besized to pass through the aperture in the tab. Furthermore, the fittingmay be positioned a distance from a proximal end of the fill tube suchthat it may allow the fill tube to be engaged with the inflation portwhile the fitting may be disposed within the aperture in someembodiments. In some instances, the fitting may include a passagethrough the fitting which may be positioned so as to allow the tab to bedisposed between the release wire and the fill tube with the releasewire disposed in the passage. In some embodiments, the fill tuberetention mechanism may further include a release wire having an outertransverse dimension and axial bending stiffness that allows the releasewire to pass through the passage of the fitting and mechanically capturethe tab to the fitting. In some cases, the elongate shaft may furtherinclude a retractable outer sheath that is disposed over the elongaterelease wire sleeve and is configured to removably cover a constrainedendoluminal prosthesis disposed on the proximal section of the elongateshaft. In some instances, the delivery catheter may further include aproximal nosecone having a bullet-shaped profile and a shoulder portionwith an outer surface which is configured to slidingly accept an innerluminal surface of the outer sheath.

Some embodiments are directed to a delivery catheter for delivery of anendoluminal prosthesis having an elongate shaft with sufficient columnstrength for percutaneous advancement within a patient's body lumen. Theelongate shaft may include a proximal section and a lumen extendingtherein in some embodiments. In some instances, a plurality ofreleasable belts disposed on the proximal section of the elongate shaftmay be configured to releasably constrain a self-expanding member of anendoluminal prosthesis. In some embodiments, a plurality of elongaterelease members may be in communication with a distal end of theelongate shaft and may include a proximal section configured toreleasably secure at least one respective releasable belt while saidreleasable belt is in a configuration that constrains at least a portionof an endoluminal prosthesis. The elongate shaft may have an elongaterelease wire sleeve disposed within the lumen extending within theelongate shaft in some cases. Additionally, the elongate release wiresleeve may include a low friction material and extend from a distalsection to a proximal section of the elongate shaft. The elongaterelease wire sleeve may include a separate lumen for each release memberin some embodiments.

Some embodiments are directed to a delivery system for percutaneousdelivery of and endoluminal prosthesis, including an elongate shaft withsufficient column strength for percutaneous advancement within apatient's body lumen. The elongate shaft may include a proximal sectionand a lumen extending therein in some embodiments. In some instances, aplurality of releasable belts disposed on the proximal section of theelongate shaft may be configured to releasably constrain aself-expanding member of an endoluminal prosthesis. In some embodiments,a plurality of elongate release members may be in communication with adistal end of the elongate shaft and may include a proximal sectionconfigured to releasably secure at least one respective releasable beltwhile said releasable belt may be in a configuration that constrains atleast a portion of an endoluminal prosthesis. In some cases, theelongate shaft may include an elongate release wire sleeve disposedwithin the lumen extending within the elongate shaft. Additionally, theelongate release wire sleeve may include a low friction materialextending from a distal section to a proximal section of the elongateshaft in some embodiments. The elongate release wire sleeve may includea separate lumen for each release member in some cases. An endoluminalprosthesis may include a tubular body portion of flexible material and aself-expanding member secured to a proximal end of the tubular bodymember in some embodiments. The endoluminal prosthesis may be releasablysecured to the proximal section of the delivery catheter by thereleasable belts disposed about and releasably constraining theself-expanding member of the endoluminal prosthesis in some embodiments.In some cases, the endoluminal prosthesis further includes an inflatableportion with an interior volume in fluid communication with an inflationport and a proximal end of the fill tube of the catheter releasablycoupled to the inflation port. In some instances, the tubular bodyportion has a bifurcated configuration. Also, the low friction materialof the elongate release wire sleeve may include a fluoropolymer such asPTFE. For some such embodiments, the PTFE of the elongate release wiresleeve may include a shore hardness of about 40 D to about 70 D and theelongate release member may include an elongate release wire or both. Insome cases, the delivery catheter may be configured to deliver aninflatable endovascular prosthesis wherein the delivery catheter mayfurther include a fill tube including a fill tube lumen extendingaxially within the elongate shaft. In some instances, the elongate shaftmay include a guidewire lumen extending from a distal section to aproximal end thereof. For some embodiments, the elongate shaft mayinclude an elongate multi-lumen member extending from a distal sectionof the elongate shaft to a proximal section of the elongate shaft, themulti-lumen member having a guidewire lumen and a lumen within which theelongate release wire sleeve is disposed. In some cases, the elongateshaft may further include a retractable outer sheath that is disposedover the elongate release wire sleeve and that is configured toremovably cover a constrained endoluminal prosthesis disposed on theproximal section of the elongate shaft. In some instances, the deliverysystem may further include a proximal nosecone including a bullet-shapedprofile and a shoulder portion having an outer surface which isconfigured to slidingly accept an inner luminal surface of the outersheath.

Some embodiments are directed to a delivery catheter for delivery of aninflatable endoluminal prosthesis including an elongate shaft which mayhave sufficient column strength for percutaneous advancement within apatient's body lumen. In some embodiments, the elongate shaft mayinclude a proximal section which may be configured to accept aninflatable endoluminal prosthesis releasably secured thereto.Additionally, a fill lumen may be in fluid communication with a distalsection of the elongate shaft and may extend to the proximal section ofthe elongate shaft in some embodiments. Some embodiments may include acollapsible low profile fill tube including an inner lumen which may bein fluid communication with the fill lumen of the elongate shaft. Insome embodiments, the collapsible fill tube may be collapsed tosubstantially eliminate a volume of the inner lumen which may have aproximal end configured to couple to an inflation port of an inflatableendoluminal prosthesis. In some cases, elongate shaft may include anelongate multi-lumen member which extends from a distal section of theelongate shaft to a proximal section of the elongate shaft, which mayhave at least a guidewire lumen and the fill lumen and which may includea fill tube cavity in a proximal end thereof configured to accept asection of the collapsible low profile fill tube that has been axiallycompressed and shortened. In some instances, the fill tube cavity mayinclude a substantially cylindrical cavity having an inner transversedimension configured to be disposed about the collapsible low profilefill tube in an axially compressed state. For some embodiments, thecollapsible low profile fill tube may include a fluoropolymer such asPTFE, which may or may not be sintered, may have a shore hardness ofabout 25 D to about 40 D, or any combination of these features. In somecases, the elongate shaft may include a guidewire lumen extending from adistal section to a proximal end thereof. In some instances, theelongate shaft may further include a retractable outer sheath that isdisposed over the collapsible low profile fill tube and fill lumen ofthe elongate shaft during delivery of an endoluminal prosthesis to atreatment site and is configured to removably cover a constrainedendoluminal prosthesis disposed on the proximal section of the elongateshaft. For some embodiments, the delivery catheter may include aproximal nose cone having a bullet-shaped profile and a shoulder portionwith an outer surface which is configured to slidingly accept an innerluminal surface of the outer sheath. In some cases, the collapsible lowprofile fill tube in a non-collapsed state may have an inner lumen witha nominal transverse dimension of about 0.5 mm to about 5 mm, may have awall thickness of about 0.02 mm to about 0.13 mm and may have an axiallength of about 5 mm to about 100 mm. In some instances, the collapsiblelow profile fill tube may have a substantially rigid proximal endconfigured to be releasably coupled to an inflation port of aninflatable endoluminal prosthesis.

Some embodiments are directed to a delivery system for percutaneousdelivery of and endoluminal prosthesis including a delivery catheter fordelivery of an inflatable endoluminal prosthesis and an inflatableendoluminal prosthesis releasably secured to the proximal section of theelongate shaft in a constrained state. In some embodiments, theprosthesis may include an inflatable portion with an interior volume influid communication with an inflation port. A proximal end of the filltube of the catheter may be releasably coupled to the inflation port insome embodiments. The inflatable endoluminal prosthesis may include anelongate shaft with sufficient column strength for percutaneousadvancement within a patient's body lumen. Additionally, the elongateshaft may include a proximal section which may be configured to acceptan inflatable endoluminal prosthesis releasably secured thereto in someembodiments. A fill lumen may be in fluid communication with a distalsection of the elongate shaft and extend to the proximal section of theelongate shaft in some cases. In some instances, a collapsible lowprofile fill tube including an inner lumen may be in fluid communicationwith the fill lumen of the elongate shaft. The collapsible fill tube maybe collapsed to substantially eliminate a volume of the inner lumen andmay have a proximal end configured to couple to an inflation port of aninflatable endoluminal prosthesis in some embodiments. For someembodiments, the inflatable endoluminal prosthesis may include a tubularbody portion with a bifurcated configuration. In some cases, elongateshaft may include an elongate multi-lumen member which extends from adistal section of the elongate shaft to a proximal section of theelongate shaft, which may have at least a guidewire lumen and the filllumen and which may include a fill tube cavity in a proximal end thereofconfigured to accept a section of the collapsible low profile fill tubethat has been axially compressed and shortened. In some instances, thefill tube cavity may include a substantially cylindrical cavity havingan inner transverse dimension configured to be disposed about thecollapsible low profile fill tube in an axially compressed state. Forsome embodiments, the collapsible low profile fill tube may include afluoropolymer such as PTFE, which may or may not be sintered, may have ashore hardness of about 25 D to about 40 D, or any combination of thesefeatures. In some cases, the elongate shaft may include a guidewirelumen extending from a distal section to a proximal end thereof. In someinstances, the elongate shaft may further include a retractable outersheath that is disposed over the collapsible low profile fill tube andfill lumen of the elongate shaft during delivery of an endoluminalprosthesis to a treatment site and is configured to removably cover aconstrained endoluminal prosthesis disposed on the proximal section ofthe elongate shaft. For some embodiments, the delivery catheter mayinclude a proximal nose cone having a bullet-shaped profile and ashoulder portion with an outer surface which is configured to slidinglyaccept an inner luminal surface of the outer sheath. In some cases, thecollapsible low profile fill tube in a non-collapsed state may have aninner lumen with a nominal transverse dimension of about 0.5 mm to about5 mm, may have a wall thickness of about 0.02 mm to about 0.13 mm andmay have an axial length of about 5 mm to about 100 mm. In someinstances, the collapsible low profile fill tube may have asubstantially rigid proximal end configured to be releasably coupled toan inflation port of an inflatable endoluminal prosthesis.

Some embodiments are directed to a delivery catheter for delivery of anendoluminal prosthesis, including an elongate shaft with sufficientcolumn strength for percutaneous advancement within a patient's bodylumen. In some embodiments, the elongate shaft may include a proximalsection and a distal section. Additionally, a plurality of releasablebelts may be disposed at the proximal section of the elongate shaftwhich may be configured to releasably constrain at least oneself-expanding member of an endoluminal prosthesis in some cases. Afirst elongate release member may be secured to a distal actuator memberat the distal section of the elongate shaft, which may include aproximal section configured to releasably secure at least one respectivereleasable belt held in a constraining configuration by the firstelongate release member. In addition, the first elongate release membermay be configured to release with the respective releasable belt uponaxial retraction of the release member or release wire in a distaldirection by a first actuation length that may be substantially thelength the first release member or release wire extends proximallybeyond the junction between the first release member and the releasablebelt in some embodiments. Additionally, a second elongate release membermay be secured to the distal actuator member at the distal section ofthe elongate shaft, which may include a proximal section configured toreleasably secure at least one respective releasable belt held in aconstraining configuration by the second elongate release member. Insome embodiments, the second elongate release member may be configuredto release with the respective releasable belt upon axial retraction ofthe second elongate release member in a distal direction by a secondactuation length that may be substantially the length the secondelongate release member extends proximally beyond the junction betweenthe second release member and the respective releasable belt. In someinstances, a flexible tether may secure the second elongate releasemember to the distal actuator. The flexible tether may include an axialslack in its length which may be as long as or longer than the actuationlength of the first elongate release member in some embodiments. In somecases, the delivery catheter may also include an elongate release wiresleeve disposed within a lumen extending within the elongate shaft, theelongate release wire sleeve including a low friction material andextending from a distal section of the elongate shaft to a proximalsection of the elongate shaft and the elongate release wire sleeve alsoincluding a separate lumen for each elongate release member. In someinstances, the delivery catheter may be configured to deliver aninflatable endovascular prosthesis wherein the delivery catheter alsoincludes a fill tube having a fill tube lumen extending axially withinthe elongate shaft. For some embodiments, the elongate shaft may includea guidewire lumen extending from a distal section to a proximal endthereof. In some cases, the elongate shaft may include an elongatemulti-lumen member extending from a distal section of the elongate shaftto a proximal section of the elongate shaft. The multi-lumen member mayalso have a guidewire lumen and a lumen within which the release wiresleeve is disposed. In some instances, the elongate shaft may furtherinclude a retractable outer sheath that is configured to removably covera constrained endoluminal prosthesis disposed on the proximal section ofthe elongate shaft. For some embodiments, the delivery catheter may alsoinclude a proximal nose cone having a bullet-shaped profile and ashoulder portion with an outer surface which is configured to slidinglyaccept an inner luminal surface of the outer sheath.

Some embodiments are directed to a delivery system for percutaneousdelivery of and endoluminal prosthesis, including an elongate shaft withsufficient column strength for percutaneous advancement within apatient's body lumen. In some embodiments, the elongate shaft mayinclude a proximal section, a distal section and a plurality ofreleasable belts disposed at the proximal section of the elongate shaftwhich are configured to releasably constrain at least one self-expandingmember of an endoluminal prosthesis. A first elongate release member orrelease wire may be secured to a distal actuator member at the distalsection of the elongate shaft, which may include a proximal sectionconfigured to releasably secure at least one respective releasable beltheld in a constraining configuration by the first elongate releasemember. In some embodiments, the first elongate release member may beconfigured to release with the respective releasable belt upon axialretraction of the release member or release wire in a distal directionby a first actuation length that may be substantially the length thefirst release member extends proximally beyond the junction between thefirst release member and the releasable belt. In some instances, asecond elongate release member may be secured to the distal actuatormember at the distal section of the elongate shaft, which may include aproximal section configured to releasably secure at least one respectivereleasable belt held in a constraining configuration by the secondelongate release member and which may be configured to release with therespective releasable belt upon axial retraction of the second elongaterelease member. In some embodiments, the second elongate release membermay be released in a distal direction by a second actuation length thatmay be substantially the length the second elongate release memberextends proximally beyond the junction between the second release memberand the respective releasable belt. A flexible tether may secure thesecond elongate release member to the distal actuator in someembodiments. The flexible tether may include an axial slack in itslength which may be as long as or longer than the actuation length ofthe first elongate release member in some cases. In some embodiments, anendoluminal prosthesis may include a tubular graft body portion offlexible material and at least one self-expanding member secured to aproximal end of the tubular body member. The endoluminal prosthesis maybe releasably secured to the proximal section of the elongate shaft bythe releasable belts disposed about and releasably constraining at leastone self-expanding member of the endoluminal prosthesis in someembodiments. In some cases, the delivery catheter may also include anelongate release wire sleeve disposed within a lumen extending withinthe elongate shaft, the elongate release wire sleeve including a lowfriction material and extending from a distal section of the elongateshaft to a proximal section of the elongate shaft and the elongaterelease wire sleeve also including a separate lumen for each elongaterelease member. In some instances, the delivery catheter may beconfigured to deliver an inflatable endovascular prosthesis wherein thedelivery catheter also includes a fill tube having a fill tube lumenextending axially within the elongate shaft. For some embodiments, theelongate shaft may include a guidewire lumen extending from a distalsection to a proximal end thereof. In some cases, the elongate shaft mayinclude an elongate multi-lumen member extending from a distal sectionof the elongate shaft to a proximal section of the elongate shaft. Themulti-lumen member may also have a guidewire lumen and a lumen withinwhich the release wire sleeve is disposed. In some instances, theelongate shaft may further include a retractable outer sheath that isconfigured to removably cover a constrained endoluminal prosthesisdisposed on the proximal section of the elongate shaft. For someembodiments, the delivery catheter may also include a proximal nose conehaving a bullet-shaped profile and a shoulder portion with an outersurface which is configured to slidingly accept an inner luminal surfaceof the outer sheath.

Some embodiments are directed to a delivery catheter for delivery of anendoluminal prosthesis, including an elongate shaft with sufficientcolumn strength for percutaneous advancement within a patient's bodylumen. In some embodiments, the elongate shaft may include a proximalsection and a distal section and a plurality of releasable beltsdisposed on the proximal section of the elongate shaft configured toreleasably constrain a self-expanding member of an endoluminalprosthesis. A plurality of elongate release members may include aproximal section configured to releasably secure at least one respectivereleasable belt while the releasable belt may be in a configuration thatconstrains at least a portion of an endoluminal prosthesis. In somecases, a release mechanism may be disposed at the distal section of theelongate shaft and in operative connection with the release members. Therelease mechanism may include a stationary main body portion secured infixed relation to the elongate shaft and a plurality of rotatingactuator rings that may be coupled to at least one elongate releasemember in some embodiments. The release mechanism may be configured toaxially retract the respective at least one elongate release member uponrotation of the respective rotating ring relative to the main bodyportion in some cases. In some cases, the rotating rings are configuredto actuate the respective release members by a camming action. In someinstances, each rotating actuator ring may include an axial position onthe release mechanism that generally corresponds to an axial position ofthe releasable belt or belts on the proximal section the rotatingactuator ring is configured to actuate. For some embodiments, thedelivery catheter may include at least one proximal releasable belt onthe proximal section of the elongate shaft configured to releasablyconstrain a proximal self-expanding member of an endoluminal prosthesis;a proximal rotating actuator ring disposed proximally of the main bodyportion of the release mechanism, coupled to a proximal elongate releasemember and configured to release the proximal releasable belt uponactuation; at least one distal releasable belt on the proximal sectionof the elongate shaft configured to releasably constrain a distalself-expanding member of an endoluminal prosthesis; and a distalrotating actuator ring disposed distally of the main body portion of therelease mechanism, coupled to a distal elongate release member andconfigured to release the distal releasable belt upon actuation. In somecases, the elongate release members may include elongate release wires.In some instances, the delivery catheter may be configured to deliver aninflatable endovascular prosthesis wherein the delivery catheter alsoincludes a fill tube having a fill tube lumen extending axially withinthe elongate shaft. For some embodiments, the elongate shaft may includea guidewire lumen extending from a distal section to a proximal endthereof. In some cases, the elongate shaft may include an elongatemulti-lumen member extending from a distal section of the elongate shaftto a proximal section of the elongate shaft. The multi-lumen member mayalso have a guidewire lumen and a lumen within which the release wiresleeve is disposed. In some instances, the elongate shaft may furtherinclude a retractable outer sheath that is configured to removably covera constrained endoluminal prosthesis disposed on the proximal section ofthe elongate shaft. For some embodiments, the delivery catheter may alsoinclude a proximal nose cone having a bullet-shaped profile and ashoulder portion with an outer surface which is configured to slidinglyaccept an inner luminal surface of the outer sheath.

Some embodiments are directed to a delivery catheter for delivery of anendoluminal prosthesis, including an elongate shaft having sufficientcolumn strength for percutaneous advancement within a patient's bodylumen. In some embodiments, the elongate shaft may include a proximalsection and a distal section and at least one releasable belt disposedon the proximal section of the elongate shaft and configured toreleasably constrain a self-expanding member of an endoluminalprosthesis. At least one elongate release member may include a proximalsection configured to releasably secure the at least one releasable beltwhile said releasable belt may be in a configuration that constrains atleast a portion of an endoluminal prosthesis. In some cases, a releasemechanism may be disposed at the distal section of the elongate shaft inoperative connection with the at least one release member. The releasemechanism may include a stationary main body portion secured in fixedrelation to the elongate shaft and at least one rotating actuator ringwhich may be coupled to the at least one elongate release member in someembodiments. The release mechanism may be configured to axially retractthe at least one elongate release member upon rotation of the rotatingring relative to the main body portion in some cases.

Some embodiments are directed to a delivery system for percutaneousdelivery of an endoluminal prosthesis, including an elongate shaft withsufficient column strength for percutaneous advancement within apatient's body lumen. In some embodiments, the elongate shaft mayinclude a proximal section and a distal section and at least onereleasable belt disposed on the proximal section of the elongate shaftand configured to releasably constrain a self-expanding member of anendoluminal prosthesis. At least one elongate release member including aproximal section configured to releasably secure the at least onereleasable belt while said releasable belt may be in a configurationthat constrains at least a portion of an endoluminal prosthesis in someembodiments. A release mechanism may be disposed at the distal sectionof the elongate shaft in operative connection with the at least onerelease member in some cases. The release mechanism may include astationary main body portion secured in fixed relation to the elongateshaft and at least one rotating actuator ring which may be coupled tothe at least one elongate release member. In some embodiments, the atleast one rotating actuator ring may be configured to axially retractthe at least one elongate release member upon rotation of the rotatingring relative to the main body portion. In some cases, an endoluminalprosthesis may include a tubular body portion of flexible material and aself-expanding member secured to a proximal end of the tubular bodymember. Additionally, the endoluminal prosthesis may be releasablysecured to the proximal section of the delivery catheter by thereleasable belts disposed about and releasably constraining theself-expanding member of the endoluminal prosthesis in some embodiments.In some cases, the rotating rings are configured to actuate therespective release members by a camming action. In some instances, eachrotating actuator ring may include an axial position on the releasemechanism that generally corresponds to an axial position of thereleasable belt or belts on the proximal section the rotating actuatorring is configured to actuate. For some embodiments, the deliverycatheter may include at least one proximal releasable belt on theproximal section of the elongate shaft configured to releasablyconstrain a proximal self-expanding member of an endoluminal prosthesis;a proximal rotating actuator ring disposed proximally of the main bodyportion of the release mechanism, coupled to a proximal elongate releasemember and configured to release the proximal releasable belt uponactuation; at least one distal releasable belt on the proximal sectionof the elongate shaft configured to releasably constrain a distalself-expanding member of an endoluminal prosthesis; and a distalrotating actuator ring disposed distally of the main body portion of therelease mechanism, coupled to a distal elongate release member andconfigured to release the distal releasable belt upon actuation. In somecases, the elongate release members may include elongate release wires.In some instances, the delivery catheter may be configured to deliver aninflatable endovascular prosthesis wherein the delivery catheter alsoincludes a fill tube having a fill tube lumen extending axially withinthe elongate shaft. For some embodiments, the elongate shaft may includea guidewire lumen extending from a distal section to a proximal endthereof. In some cases, the elongate shaft may include an elongatemulti-lumen member extending from a distal section of the elongate shaftto a proximal section of the elongate shaft. The multi-lumen member mayalso have a guidewire lumen and a lumen within which the release wiresleeve is disposed. In some instances, the elongate shaft may furtherinclude a retractable outer sheath that is configured to removably covera constrained endoluminal prosthesis disposed on the proximal section ofthe elongate shaft. For some embodiments, the delivery catheter may alsoinclude a proximal nose cone having a bullet-shaped profile and ashoulder portion with an outer surface which is configured to slidinglyaccept an inner luminal surface of the outer sheath.

Some embodiments are directed to a delivery system for percutaneousdelivery of and endoluminal prosthesis, including an elongate shafthaving sufficient column strength for percutaneous advancement within apatient's body lumen. In some embodiments, the elongate shaft mayinclude a proximal section, a distal section and a retractable outersheath extending from the proximal section to the distal section. Theretractable outer sheath may be configured to removably cover aconstrained endoluminal prosthesis disposed on the proximal section ofthe elongate shaft in some embodiments. A grip device may be disposedover a distal section of the outer sheath and may include an egg shapedelastomer body in some embodiments. In some cases, the egg shapedelastomer body may include a bore extending axially therethrough. Thebore may have an inner transverse dimension configured to slide over anouter surface of the retractable outer sheath and make contact with andfrictionally grip the outer surface of the outer retractable sheath whenmanually squeezed from an outside surface of the grip device in someembodiments. In some cases, the elastomer body of the grip device mayinclude a longitudinal slot communicating with the bore and outsidesurface of the elastomer body and configured to allow the elastomer bodyto be spread open for lateral insertion or removal of the outerretractable sheath relative to the bore. In some instances, theelastomer body may include an elastomer having a shore hardness of about20 A to about 40 A, a material selected from the group consisting ofrubber, polyurethane and silicone or any combination of these features.For some embodiments, the elastomer body may include a major outertransverse dimension of about 15 mm to about 50 mm, an axial length ofabout 500 mm to about 700 mm or both. In some cases, the bore in theelastomer body may be configured to have clearance between an innersurface of the bore and an outer surface of the retractable outer sheathof up to about 2 mm. In some instances, the inner surface of the boremay have a coefficient of friction of about 0.6 to about 0.95.

Some embodiments are directed to a grip device configured to be disposedover a distal section of a retractable outer sheath of a delivery systemfor delivery of an endoluminal prosthesis. In some embodiments, the gripdevice may have an egg shaped elastomer body including a bore extendingaxially therethrough. The bore may have an inner transverse dimensionconfigured to slide over an outer surface of a retractable outer sheathand make contact with and frictionally grip the outer surface of theouter retractable sheath when manually squeezed from an outside surfaceof the grip device in some embodiments. In some cases, the elastomerbody of the grip device may include a longitudinal slot whichcommunicates between the bore and an outside surface of the elastomerbody and which is configured to allow the elastomer body to be spreadopen for lateral insertion or removal of an outer retractable sheathrelative to the bore. In some instances, the elastomer body may includean elastomer having a shore hardness of about 20 A to about 40 A, amaterial selected from the group consisting of rubber, polyurethane andsilicone or any combination of these features. For some embodiments, theelastomer body may include a major outer transverse dimension of about15 mm to about 50 mm, an axial length of about 500 mm to about 700 mm orboth. In some cases, the bore in the elastomer body may be configured tohave clearance between an inner surface of the bore and an outer surfaceof the retractable outer sheath of up to about 2 mm. In some instances,the inner surface of the bore may have a coefficient of friction ofabout 0.6 to about 0.95.

Some embodiments are directed to a method of manually retracting aretractable outer sheath of a delivery system for delivery of anendoluminal prosthesis, including advancing a delivery system forpercutaneous delivery of an endoluminal prosthesis to a treatment sitewithin a patient's body lumen. Some methods may include manuallygrasping the grip device and applying inward radial pressure with thegrip such that an inner luminal surface of the bore engages the outersurface of the retractable outer sheath. Additionally, some methods mayinclude manually moving the grip device in an axial direction relativeto the elongate shaft of the delivery system while the inner surface ofthe bore may be engaged with the outer surface of the retractable outersheath. In some embodiments, the delivery system may include an elongateshaft with sufficient column strength for percutaneous advancementwithin a patient's body lumen. The elongate shaft may include a proximalsection, a distal section and a retractable outer sheath extending fromthe proximal section to the distal section and configured to removablycover a constrained endoluminal prosthesis disposed on the proximalsection of the elongate shaft in some embodiments. Additionally, a gripdevice may be disposed over a distal section of the outer sheath whichmay include an egg shaped elastomer body in some embodiments. The eggshaped elastomer body may include a bore extending axially therethrough.In some embodiments, the bore may have an inner transverse dimensionconfigured to slide over an outer surface of the retractable outersheath and make contact with and frictionally grip the outer surface ofthe outer retractable sheath when manually squeezed from an outsidesurface of the grip device. In some cases, the grip device may beaxially moved in a distal direction relative to the elongate shaft untilan endoluminal prosthesis in a constrained state disposed on a proximalsection of the elongate shaft is fully exposed. In some instances, thedelivery system may be advanced for percutaneous delivery of anendoluminal prosthesis to the treatment site within the patient's bodylumen over a guidewire. For some device embodiments, the grip device mayfurther include a longitudinal slot which communicates between the boreand an outside surface of the elastomer body and which is configured toallow the elastomer body to be spread open for lateral insertion orremoval of the outer retractable sheath relative to the bore. In suchcases, the method may also include spreading the longitudinal slot inthe elastomer body and passing the retractable outer sheath through thelongitudinal slot and into the bore.

Certain embodiments are described further in the following description,examples, claims and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a delivery catheter system embodiment disposed over aguidewire embodiment.

FIG. 1A illustrates the delivery catheter system of FIG. 1 with an outersheath of the delivery catheter system retracted distally.

FIG. 2 is an elevation view of the delivery catheter system of FIG. 1illustrating a proximal self-expanding member and fill tube retentionmechanism embodiment.

FIG. 3 is an elevation view of a junction between tubular members of theinflation conduit embodiment of the fill tube retention mechanism ofFIG. 2 indicated by the encircled portion 3 in FIG. 2.

FIG. 4 is a top view of the junction of FIG. 3 showing the fill tuberetention mechanism embodiment at the distal end of the tubular maingraft body portion of the endoluminal prosthesis and illustrating a tab,release wire, fill tube, and two fittings.

FIG. 5 is a transverse cross section view of a fitting of FIG. 3 takenalong lines 5-5 of FIG. 3 and illustrating an axial lumen for a releasewire and a lumen for a fill tube.

FIG. 6 is a transverse cross section view of the distal end of thetubular main graft body portion of the endoluminal prosthesis of FIG. 3taken along lines 6-6 of FIG. 3.

FIG. 7 is an elevation view of the junction between tubular members ofan inflation conduit embodiment of the fill tube retention mechanism ofFIG. 2 illustrating retraction of the release wire from the endoluminalprosthesis.

FIG. 8 illustrates retraction of the release wire from the tab and thefittings of the system of FIG. 7.

FIG. 9 illustrates retraction of the fill tube from the inflation portof the system of FIG. 7 and retraction of the tab from the fitting.

FIG. 10 illustrates distal retraction of the fill tube away from theendoluminal prosthesis and inflation port.

FIG. 10A is an elevation view of the junction between tubular members ofan inflation conduit embodiment of the fill tube retention mechanismwith fittings extending from an extension member.

FIG. 11 illustrates a distal self-expanding member and distal portion ofan endoluminal prosthesis embodiment.

FIG. 12 is an enlarged view of a distal self-expanding member of thedevice of FIG. 11 illustrating a tab at a distal portion of the distalself-expanding member.

FIG. 13 is an enlarged view of FIG. 11 illustrating a release wire, filltube, distal self-expanding member tab feature and two fittings.

FIG. 14 is an elevation view in longitudinal section of the endoluminalprosthesis embodiment of FIG. 2 indicated by the encircled portion 14 inFIG. 2 illustrating a proximal section of an elongate shaft havingmulti-lumen configuration and the proximal end of the endoluminalprosthesis.

FIG. 15 is a transverse cross sectional view of the endoluminalprosthesis of FIG. 14 taken along lines of 15-15 of FIG. 14 andillustrating the multi-lumen configuration of the proximal section ofthe elongate shaft.

FIG. 16 illustrates a delivery catheter system embodiment disposed overa guidewire embodiment.

FIG. 17 illustrates the delivery system of FIG. 16 with an outer sheathof the delivery catheter system retracted distally exposing anendoluminal prosthesis embodiment.

FIG. 18 illustrates a delivery catheter system embodiment disposed overa guidewire embodiment within a patient's thoracic aorta and crossing athoracic aortic aneurysm.

FIG. 19 illustrates the endoluminal prosthesis of FIG. 18 in a deployedstate.

FIG. 20 is an elevation view of the elongated shaft, distalself-expanding member and graft body of an endoluminal prosthesisembodiment of FIG. 17.

FIG. 21 is an elevation view in partial longitudinal section of thejunction between tubular members of the inflation conduit embodiment ofFIG. 20 at the encircled portion 21 of FIG. 20, illustrating a tear awayportion of the fill tube within the multi-lumen shaft with the distalself-expanding member not shown for purposes of clarity of illustration.

FIG. 22 illustrates a longitudinal section of a fill tube in connectionwith the inflation port.

FIG. 23 illustrates a longitudinal section of a fill tube within themulti-lumen shaft having storage of excess transitional fill tubing.

FIG. 24 is an elevation view of the proximal stent and the distalself-expanding member of the endoluminal prosthesis of FIG. 17.

FIG. 24A is a transverse cross section view of the prosthesis of FIG. 24taken along lines 24A-24A of FIG. 24.

FIG. 24B is a transverse cross section view of the prosthesis of FIG. 24taken along lines 24B-24B of FIG. 24.

FIG. 25 is an elevation view in longitudinal section of a distal adapterembodiment of a delivery system.

FIG. 26 is an elevation view in partial section of a portion of thedistal adapter embodiment of FIG. 25 indicated by the encircled portion26 in FIG. 25.

FIG. 26A illustrates a delivery system embodiment having a distaladapter with distal and proximal release wires and a flexible tether.

FIG. 26B illustrates the delivery catheter system embodiment of FIG. 26Aafter actuation of the proximal release wires by displacement of therelease or actuator cap.

FIG. 26C is a transverse cross sectional view of the elongate shaft ofFIG. 26 taken along lines of 26C-26C of FIG. 26 and illustrating amulti-lumen elongate release wire sleeve.

FIG. 27 is an elevation view of a rotating handle distal adapterembodiment of a delivery catheter system.

FIG. 28 is an elevation view in a longitudinal section of the rotatinghandle distal adapter embodiment of FIG. 27 taken along lines 28-28 ofFIG. 27 illustrating a rotation actuator for the release wires.

FIG. 29 is an elevation view of a delivery catheter system embodimentdisposed over a guidewire embodiment and a gripper device.

FIG. 30 illustrates the gripper device embodiment of FIG. 29 placed onthe delivery catheter system and being actuated by the hands of a user.

FIG. 31 is an elevation view of the gripper device of FIG. 30 disposedover a distal section of the outer sheath of a delivery catheter systemembodiment.

FIG. 32 is a transverse cross section view of the gripper device of FIG.31 taken along lines 32-32 of FIG. 31 illustrating a lumen of thegripper device disposed over and engaging an outer surface of thedelivery catheter system.

FIG. 33 is an elevation view in partial section of the gripper device ofFIG. 31 taken along lines 33-33 of FIG. 31 illustrating the coupling ofthe gripper device over the outer sheath of the delivery cathetersystem.

The drawings illustrate embodiments of the invention and are notlimiting. For clarity and ease of illustration, the drawings are notmade to scale and, in some instances, various aspects may be shownexaggerated or enlarged to facilitate an understanding of particularembodiments.

DETAILED DESCRIPTION

Some embodiments may be directed generally to methods and devices fortreatment of fluid flow vessels with the body of a patient. Treatment ofblood vessels is specifically indicated for some embodiments, and, morespecifically, treatment of aneurysms, such as abdominal aorticaneurysms.

Some embodiments of a modular endovascular graft assembly may include abifurcated main graft member formed from a supple graft material, suchas ePTFE, having a main fluid flow lumen therein. The main graft bodymember may also include an ipsilateral leg with an ipsilateral fluidflow lumen in communication with the main fluid flow lumen, acontralateral leg with a contralateral fluid flow lumen in communicationwith the main fluid flow lumen and a network of inflatable channelsdisposed on the main graft member. For some embodiments, the main graftbody member may have an axial length of about 5 cm to about 10 cm, morespecifically, about 6 cm to about 8 cm in order to span an aneurysm of apatient's aorta without engaging the patient's iliac arteries directlywith the legs of the main graft member.

The inflatable channels of the network of inflatable channels may bedisposed on any portion of the main graft body member including theipsilateral and contralateral legs. The network of inflatable channelsmay be configured to accept a hardenable fill material to providestructural rigidity to the main graft body member when the network ofinflatable channels are in an inflated state and the inflation materialhas been cured or hardened. Radiopaque inflation material may be used tofacilitate monitoring of the fill process and subsequent engagement ofgraft extensions. The network of inflatable channels may also include atleast one inflatable cuff disposed on a proximal portion of the maingraft body member which is configured to seal against an inside surfaceof a patient's vessel, such as the aorta.

A proximal anchor member may be disposed at a proximal end of the maingraft member and secured to the main graft body member. The proximalanchor member may have a self-expanding proximal stent portion securedto a distal self-expanding member having struts. Some embodiments of thestruts may have a cross sectional area that may be substantially thesame as or greater than a cross sectional area of proximal stentportions or distal stent portions adjacent the strut. Such aconfiguration may be useful in avoiding points of concentrated stress inthe proximal anchor member or struts which couple components thereof.For some embodiments, the proximal stent of the proximal anchor memberfurther includes a plurality of barbs having sharp tissue engaging tipsthat are configured to extend in a radial outward direction in adeployed expanded state. For some embodiments, the proximal anchormember includes a 4 crown proximal stent portion and a 8 crown distalstent portion which may be made from a superelastic alloy such assuperelastic NiTi alloy.

At least one ipsilateral graft body extension having a fluid flow lumendisposed therein may be deployed with the fluid flow lumen of the graftbody extension sealed to and in fluid communication with the fluid flowlumen of the ipsilateral leg of the main graft body member. In addition,at least one contralateral graft extension having a fluid flow lumendisposed therein may be deployed with the fluid flow lumen of the graftextension sealed to and in fluid communication with the fluid flow lumenof the contralateral leg of the main graft member. For some embodiments,the graft extensions may include an interposed self-expanding memberdisposed between at least one outer layer and at least one inner layerof supple layers of graft material. The interposed self-expanding memberdisposed between the outer layer and inner layer of graft material maybe formed from an elongate resilient element helically wound with aplurality of longitudinally spaced turns into an open tubularconfiguration. For some embodiments, the interposed self-expandingmember or stent may include a superelastic alloy such as superelasticNiTi alloy. In addition, the graft material of each graft body extensionmay further include at least one axial zone of low permeability for someembodiments.

For some embodiments, an outside surface of the graft extension may besealed to an inside surface of the contralateral leg of the main graftwhen the graft extension is in a deployed state. For some embodiments,the axial length of the ipsilateral and contralateral legs may besufficient to provide adequate surface area contact with outer surfacesof graft extensions to provide sufficient friction to hold the graftextensions in place. For some embodiments, the ipsilateral andcontralateral legs may have an axial length of at least about 2 cm. Forsome embodiments, the ipsilateral and contralateral legs may have anaxial length of about 2 cm to about 6 cm, more specifically, about 3 cmto about 5 cm.

With regard to graft embodiments discussed herein, such as graftassembly 10, and components thereof, as well as graft extensions, theterm “proximal” refers to a location towards a patient's heart and theterm “distal” refers to a location away from the patient's heart. Withregard to delivery system catheters and components thereof discussedherein, the term “proximal” refers to a location that is disposed awayfrom an operator who is using the catheter and the term “distal” refersto a location towards the operator.

FIGS. 1-13 show a delivery catheter embodiment 100 having a fill tuberetention mechanism for facilitating inflation of an inflatableendoluminal prosthesis or stent graft 110 for treatment of an aorticaneurysm in a patient. FIGS. 14-15 illustrate multi-lumen configurationin a multi-lumen release wire housing embodiment of a delivery cathetersystem. FIGS. 16-20 illustrate a delivery catheter embodiment structurefor deployment of the endoluminal prosthesis assembly. FIGS. 21-23illustrate a fill tube lumen embodiment. FIGS. 24-26 illustrate anembodiment of multi-stage deployment of an endoluminal prosthesis usingproximal and distal release wires. FIGS. 27-28 illustrate a rotatinghandle distal actuator embodiment which may be used to actuate theproximal and distal release wires of a delivery catheter. FIGS. 29-33illustrate a grip device embodiment which may attach over a section ofan outer sheath of a delivery catheter system in order to improve auser's grip on the delivery catheter system.

Referring again to FIGS. 1-13, the delivery catheter 100 contains anendoluminal prosthesis or stent graft 110 in a radially constrainedstate and a distal adapter 102. Such a delivery catheter 100 may includesome or all of the features, dimensions or materials of delivery systemsdiscussed in commonly owned U.S. Patent Application Publication No.2004/0138734, published Jul. 15, 2004, filed Oct. 16, 2003, by Chobotovet al., titled “Delivery System and Method for Bifurcated Graft” whichis incorporated by reference herein in its entirety and in the PCTInternational Publication No. WO 02/083038, published Oct. 24, 2002,filed Apr. 11, 2001, by Chobotov et al., titled “Delivery System andMethod for Bifurcated Graft” which is incorporated by reference hereinin its entirety. FIG. 1A shows the outer sheath 104 of the deliverycatheter 100 retracted distally. The endoluminal prosthesis 100, or anyother prosthesis discussed herein, may include some or all of thefeatures, dimensions or materials of the prostheses discussed incommonly owned U.S. Patent Publication No. 2009/0099649, filed Oct. 3,2008, by Chobotov et al., titled Modular Vascular Graft for Low ProfilePercutaneous Delivery, which is incorporated by reference herein in itsentirety. Once the outer sheath 104 of the delivery catheter 100 isretracted, the endoluminal prosthesis 110 (which may be releasablysecured to the delivery catheter 100 with the proximal self-expandingmember 116 in a constrained state) may be exposed. The endoluminalprosthesis 110 may be releasably secured to a proximal section of thedelivery catheter 100 and may include an inflatable portion with aninterior volume in fluid communication with an inflation port 106 and aproximal end of the fill tube 108 of the catheter releasably coupled tothe inflation port 106 as shown in FIG. 3. For some embodiments,retraction of the outer sheath 104 from the endoluminal prosthesis 110may put the endoluminal prosthesis 110 in a partially deployed state.

In FIG. 2, the proximal self-expanding member 116 of the endoluminalprosthesis 110 is shown as being restrained by a first releasable beltmember 112 and a second releasable belt member 114 which may be disposedabout a proximal section and distal section of the proximalself-expanding member 116. Looped ends of the first belt member 112 maybe releasably secured together with a first release wire 118 which maypass through the looped ends of the first belt member 112. Looped endsof the second belt member 114 may be releasably secured together with asecond release wire 119 which may pass through the looped ends of thesecond belt member 114. The first belt member 112 may be released byretraction in a distal direction of the first release wire 118 so as toremove the circumferential constraint of the first belt member 112 aboutthe distal section of the proximal self-expanding member 116. Removal ofthe circumferential constraint of the first belt member 112 may be usedto partially deploy the endoluminal prosthesis 110.

For the particular endoluminal prosthesis 110 and inflation conduitconfiguration 150 shown in FIG. 3, the distal section of the deliverycatheter 100 may have a fill tube 108 extending from the catheter. Thefill tube 108 may have a transverse dimension of about 1 mm to about 2mm. The fill tube 108 may also be configured to be coupled to and influid communication with the distal end of the inflation port (fillport) 106. The fill tube 108 may also be uncoupled from the inflationport 106. The fill tube's 108 outer transverse dimension may beconfigured to slide within an inner lumen 120 of the inflation port 106and provide a seal there between for viscous fluids.

A tab or flap extension 122 of the graft body of the prosthesis 110 mayinterlock with one or more fittings 124 of the fill tube assembly whichmay releasably secure the tubular members of the inflation conduit 150.In FIG. 3, the tab 122 is shown by way of example as protruding from adistal portion of the graft body 126 of the endoluminal prosthesis 110.The graft body 126 may be made from a flexible, collapsible material,such as PTFE, or the like. Additionally, the tab 122 may be made from aflexible, collapsible material, such as PTFE, or the like. The tab 122may be part of the graft body 126, an extension of the graft body 126,or a separate member secured directly or indirectly to the graft body126. The tab 122 may have one or more apertures 123 where one or morefittings 124 can be releasably secured. The tab 122 may be located at asubstantially fixed relation to the inflation port 106. A fitting 124may be secured to a proximal portion of the fill tube 108 and may extendlaterally from the fill tube 108. The fitting 124 includes at least aportion that may be sized to pass through the aperture 123 in the tab122, which may be disposed a distance from a proximal end of the filltube 108 allowing the fill tube 108 to be engaged with the inflationport 106 while the fitting 124 may be disposed within the tab's aperture123. The aperture 123 of the tab 122 may be configured to fit an outertransverse surface of the fitting 124.

FIG. 4 is a top view of the fill tube 108 retention mechanism embodimentof FIG. 3 illustrating placement of the fill tube 108 underneath the tabextension 122 of the graft body 126 and the tab 122 releasably securedto one of the fittings 124. The fitting 124 may also include one or moreapertures/passages 130 for at least one release wire 128 to pass throughit longitudinally or along the direction of the delivery catheter 100 inorder to mechanically capture a portion of the tab 122 between therelease wire 128, fittings 124 and fill tube 108. FIG. 5 shows atransverse cross section view of a fitting 124 of FIG. 3 taken alonglines 5-5 of FIG. 3 and illustrates a smaller axial lumen 130 for arelease wire 128 and a larger lumen 129 for a fill tube 108. A fitting124 may also have only one axial lumen for a release wire 128 which mayaid in supporting the release wire 128. A plurality of fittings 124 maybe used, one or more for engaging the tab 122 and/or one or more forsupporting the release wire 128. The axial passage 130 of the fitting124 may be substantially parallel to the lumen 109 of the fill tube 108.A release wire 128 passes from the delivery catheter 100 through thepassage 130 of the fitting 124 to mechanically capture the tab 122 tothe fitting 124 with the tab 122 disposed between the release wire 128and the fill tube 108 and the release wire 128 disposed in the passage130. The release wire 128 may also extend proximally from the passage130 of the fitting 124 into a pocket in a portion of the graft body 126(pocket not illustrated in figures). The release wire 128 may extendfrom the passage 130 in the fitting 124 to a release mechanism disposedat the distal section of the delivery catheter 100 which may beconfigured to apply axial tension and displacement to the release wire128 in order to axially retract the release wire 128 and release thefitting 124 from the aperture 123 of the tab 122.

FIG. 6 shows a transverse cross section view of the inflation conduit150 at the distal end of the graft body 126 of FIG. 3 taken along lines6-6 of FIG. 3. The graft body 126 may have a substantially tubularconfiguration and have a wall portion 127 that bounds a main fluid flowlumen 125 disposed therein. FIG. 6 illustrates an exemplary embodimentof the distal end of the inflation conduit 150. The inflation conduitembodiment 150 may also include an inflation port 106 which may be influid communication with an exterior portion of the graft body 126 ormay be otherwise disposed at a location or site that is exterior to aninterior volume of the inflatable portion of the endoluminal prosthesis110. The inflation port 106 may be in fluid communication with an innerlumen 158 within the inflation conduit 150 which may be in fluidcommunication with an outlet port (not shown). Some endoluminalprosthesis 110 may include an optional inflation conduit 150 which mayserve as a fill manifold for inflation of an inflatable portion ofinflatable embodiments of endoluminal prosthesis 110. Such inflationconduit 150 embodiments may be used to inflate inflatable portions ofthe endoluminal prosthesis 110 from a desired site or sites within theinflatable portion. Inflation conduit 150 embodiments may include atleast one outlet port, disposed at any desired position or desiredpositions within the inflatable portion of the endoluminal prosthesis110. The outlet port embodiment may be disposed at a proximal end of theinflation conduit 150. The inflation conduit 150 may have a singleoutlet port positioned at a desired position within the inflatableportion and may be configured to first fill the inflatable portion ofthe endoluminal prosthesis from the desired position within an interiorvolume of the inflatable portion of the endoluminal prosthesis 110.

For some embodiments, the inflatable portion of the endoluminalprosthesis 110 may include one or more inflatable channels formed fromthe flexible material of the graft body 126 section including the maingraft body section and legs (not shown). The inflation conduit 150 maybe disposed within an interior volume of a longitudinal inflatablechannel 153 (see FIG. 19) of the network of inflatable channels and maybe configured to fill the network of inflatable channels from a desiredposition within an interior volume of a proximal inflatable cuff of thegraft body 126 portion of the endoluminal prosthesis 110. The inflationconduit 150 includes a distal end with an inflation port 106 disposed atthe distal end.

When fill material is emitted under pressure from the outlet port of theinflation conduit 150, the fill material may first begin to fill aproximal inflatable cuff 151 (see FIG. 19). This arrangement may allow aseal to be formed between an outside surface of the proximal cuff and aluminal surface of the patient's vasculature at the initial inflationstage. Such a seal may force a flow of blood through the main lumen ofthe endoluminal prosthesis 110 and allow the graft body 126 of theendoluminal prosthesis 110 to open sequentially in a “windsock” typedeployment process. A windsock type deployment process may be useful insome circumstances in order to maintain control of the deploymentprocess of the endoluminal prosthesis 110.

The inflation conduit 150, an inner lumen 158 of which may be incommunication between a location outside the inflatable portion of theendoluminal prosthesis 110 and an interior volume of the inflatableportion, may be disposed within any desired portion of the inflatableportion. Inflation conduit 150 embodiments disposed within the interiorvolume of the inflatable portion may include a variety of configurationswith regard to the size or area and position of the outlet port orports. The inflation conduit 150 may have a single outlet port disposedat the proximal end of the inflation conduit 150. The outlet port may bedisposed within the interior volume of the proximal inflatable cuff 151disposed at the proximal end of the graft body 126 portion. The positionof the outlet port may be configured to emit fill material injected intothe inflation conduit 150 from the outlet port so as to first inflatethe proximal inflatable cuff 151, as discussed above. The inflationconduit 150 may extend distally from the outlet port and may be disposedwithin the longitudinal inflatable channel 153 of the inflatable portionof the endoluminal prosthesis 110. The longitudinal inflatable channelmay extend distally from the proximal inflatable cuff 151.

Some inflation conduit 150 embodiments may be made from a flexible,collapsible material, such as PTFE. For such embodiments, it may bedesirable to have an elongate bead, not shown, disposed within an innerlumen 158 of the inflation conduit 150. Such a bead may be made from aflexible but substantially incompressible material, such as a solid PTFEextrusion with or without a radiopaque additive doping (bismuth, bariumor other commonly used radiopaque extrusion additives). Bead embodimentsmay be useful for maintaining a patent lumen passage through theinflation conduit 150 when the endoluminal prosthesis 110 and inflatableportion thereof may be in a constrained state prior to deployment. Thisconfiguration may also allow the inflation conduit 150 of theendoluminal prosthesis 110 to be visible under fluoroscopy fororientation purposes throughout the deployment process prior toinflation of the inflatable portion with fill material. A distal end ofthe bead may be secured at any axial position within the inner lumen ofthe inflation conduit 150, but may also be secured to a distal portionof the inflation conduit 150.

FIGS. 7-10A are elevation views of the junction between tubular membersof the inflation conduit 150 embodiment of the fill tube retentionmechanism of FIG. 2 illustrating the sequence of retraction of therelease wire 128 from the graft body 126 followed by retraction from thefittings 124, so as to release the portion of the tab 122 which ismechanically captured by the release wire 128. Once this occurs,detachment may further include retraction of the tab aperture 123 fromthe fitting 124, and retraction of the fill tube 108 from the inflationport 106. FIG. 7 shows distal movement of the release wire 128 from apocket (not shown) in the graft body 126 portion. The release wire 128may extend from the fitting 124 to a distal end of the delivery catheter100 and may be coupled to a release mechanism disposed at a distal endof the delivery catheter 100 in order to apply axial tension anddisplacement to the release wire 128. This axial displacement serves toand axially retract the release wire 128 from passage 130 of fittings124. Thereafter, aperture 123 of the tab 122 of the graft body 126 isfree to slide off the fitting 124. The delivery catheter 100 may haveone or more release wires 128 for securing the fill tube 108 to theinflation port 106. FIG. 8 shows further distal retraction of therelease wire 128 from the fittings 124. FIG. 9 shows an example of theaperture 123 of the tab 122 sliding off and being removed from thefitting 124. Thereafter, the fill tube 108 may be disjoined or otherwiseseparated from the inflation port 106. FIG. 10 shows an example ofdistal retraction of the fill tube 108 with fittings 124 from the distalend of the endoluminal prosthesis 110. FIG. 10A illustrates anembodiment of the junction between tubular members of the inflationconduit 150 of the fill tube retention mechanism. In this embodiment,one or more fittings 124 may mechanically couple to and extend from anextension member 131 instead of the fill tube 108. In some cases, theextension member 131 may be secured to the elongate shaft 152 or anyother suitable location of the delivery catheter assembly 100. For suchan embodiment, the extension member 131 may be axially displacedindependent of the fill tube 108 if desired. In addition, for theembodiment shown, each of the multiple fittings 124 passes through aseparate respective aperture 123 such that there is mechanicalengagement and capture by release wire 128 disposed through passages 130of a plurality of fittings 124 which are disposed through a plurality ofrespective apertures 123 in tab 122. Such an arrangement may bedesirable in order to provide some redundancy to the retention of thefill tube 108 to the port 106.

FIGS. 11-13 show a distal portion of an endoluminal prosthesis 110embodiment including an aperture 134 that may releasably secure one ormore fittings 124. FIG. 12 shows an enlarged view of a distalself-expanding member 117 including an aperture 134 which releasablysecures the tubular members of the inflation conduit 150. The distalself-expanding member 117 may include a “tab” feature 135 having anaperture 134. The tab feature 135 of the distal self-expanding member117 may have one or more apertures 134 to which one or more fittings 124may be may be mechanically captured or otherwise releasably secured.FIG. 13 shows an embodiment where the tab feature 135 which may belocated at a substantially fixed relation to the inflation port 106. Afitting 124 may be secured to a proximal portion of the fill tube 108and may extend laterally from the fill tube 108. The fitting 124includes at least a portion that may be sized to pass through theaperture 134 in the tab feature 135, which may be disposed at a distancefrom a proximal end of the fill tube 108 allowing the fill tube 108 tobe engaged with the inflation port 106 while the fitting 124 may bedisposed within the tab feature's 135 aperture 134. The aperture 134 ofthe tab feature 135 may fit an outer transverse surface of the fitting124. The tab feature 135 may be an extension of a distal self-expandingmember 117 of the endoluminal prosthesis 110. The tab feature 135 may bea part of a distal self-expanding member 117 or a separated piece inconnection with the distal self-expanding member 117. The distalself-expanding member 117 and tab feature 135 may include or be madefrom a metal, for example a superelastic alloy such as superelastic NiTialloy.

FIG. 14 shows a proximal section of an elongated shaft 152 having amulti-lumen configuration and a multi-lumen element configured to housemultiple release wires disposed therein. The release wires may beconfigured to deploy a self-expanding member at a proximal end of theendoluminal prosthesis 110. FIG. 15 shows a transverse cross sectionalview of the elongate shaft 152 and endoluminal prosthesis 110 of FIG. 14illustrating the multi-lumen configuration of the proximal section ofthe elongated shaft 152. The graft body 126 may be formed from aflexible and supple graft material, such as PTFE, and have a main fluidflow lumen 125 therein. For some embodiments, flexible graft materialincluding PTFE may include expanded PTFE or ePTFE. The delivery catheter100 may include an elongate shaft 152 with sufficient column strengthfor percutaneous advancement within a patient's body lumen. The elongateshaft 152 may include a proximal section 153 and at least one lumenextending therein. The first belt 112 and second belt 114 may beconfigured to releasably constrain the proximal self-expanding member116 along a proximal section 153 of the elongated shaft 152.

In addition, at least the first release wire 118 and second release wire119 may extend to and be in communication with a distal end of theelongate shaft 152. The first release wire 118 and second release wire119 may have a proximal section configured to releasably secure at leastone respective releasable belt, such as the first belt 112 and secondbelt 114, while the releasable belts are in a configuration thatconstrains at least a portion of the endoluminal prosthesis 110, such asthe proximal self-expanding member 116. The elongate shaft 152 may havea multi-lumen elongate release wire sleeve 154 disposed therein whichextends within the multi-lumen elongate shaft 152. The elongate releasewire sleeve 154 may include or be made from a low friction material andextends from approximately a distal section 151 to a proximal section153 of the elongate shaft 152. The low friction material may contain afluoropolymer or a combination thereof, or contain PTFE for example. ThePTFE may have a shore hardness of about 40 D to about 70 D. The elongaterelease wire sleeve 154 may have a separate lumen for each releasemember, such as a first lumen for the first release wire 118 and asecond lumen for the second release wire 119. One or more elongaterelease members may include or be in connection with an elongate releasewire 128.

The elongate shaft 152 may have a multi-lumen configuration, wherein oneor more lumens are within the elongate shaft lumen 159. The elongateshaft lumen 159 may contain an elongate multi-lumen member which extendsfrom a distal section 151 of the elongate shaft 152 to a proximalsection 153 of the elongate shaft 152 (see also FIG. 16). Themulti-lumen member embodiment of the elongate shaft 152 may contain aguidewire lumen 160 and a release wire lumen 162 within which themulti-lumen release wire sleeve 154 may be disposed. The elongate shaftlumen 152 may also contain a fill tube lumen 164 which may extendaxially. The guidewire lumen 160 may extend from a distal section 151 toa proximal section 153 thereof. The release wire lumen 162 may have oneor more release wire sleeves 154 disposed within. For example, for athoracic endoluminal prosthesis two release wire sleeves 154 or a duellumen may be disposed within the release wire lumen 162. For anabdominal endoluminal prosthesis three release wire sleeves 154 or atri-lumen may be disposed within the release wire lumen 162. Aretractable outer sheath 104 may be disposed over the elongate shaft 152and the elongate release wire sleeve 154 and may be configured toremovably cover a constrained endoluminal prosthesis 110 disposed on theproximal section 153 of the elongate shaft 152. The delivery catheter100 may also include a proximal nosecone 170 which may have abullet-shaped profile and a shoulder portion having an outer surfacewhich may be configured to slidingly accept an inner luminal surface ofthe retractable outer sheath 104.

FIGS. 16-19 show structures and the delivery system for a thoracicendoluminal prosthesis. FIG. 16 shows a delivery catheter 100 embodimentincluding a guidewire lumen 160. An elongate shaft 152 and proximalnosecone 170 are also shown. FIG. 17 shows the delivery catheter 100with the outer sheath 104 retracted distally and exposing an endoluminalprosthesis 110 embodiment. A distal self-expanding member 117, graftbody 126 and proximal self-expanding member 116 are also shown. FIG. 18shows the delivery catheter 100 system within a patient's thoracic aortawith the guidewire 172 crossing through the thoracic aortic aneurysm174. FIG. 19 shows a completely deployed thoracic aortic aneurysmendoluminal prosthesis 110 within a patient's body, where the proximalnosecone 170 may be proximal to the endoluminal prosthesis 110 and thefill tube 108 may be releasably secured to the inflation conduit 150.The endoluminal prosthesis 110 includes graft body 126 which has a wallportion 127 that bounds a main fluid flow lumen 125 disposed therein.

The graft body 126 has a tubular body portion which generally may have alarge transverse dimension and area. The graft body 126 may be made of aflexible material and has at least one proximal self-expanding member116 secured to a proximal end of the tubular graft body 126 member. Inaddition, a proximal anchor member may also be disposed at a proximalend of the graft body 126. The proximal anchor member may include anadditional proximal self-expanding member 116 that may be formed from atleast one elongate element having a generally serpentine shape with, forexample, four crowns or apices at either end. Each proximal apex orcrown of the proximal self-expanding member 116 may be coupled toalternating distal crowns or apices of an additional 8 crown proximalself-expanding member 116. The distal end of the proximal self-expandingmember 116 adjacent the graft body 126 may be formed from an elongateelement having a generally serpentine shape. Additionally, the distalend of the proximal self-expanding member 116 adjacent the graft body126 may be mechanically coupled to a connector ring (not shown) whichmay be embedded in the graft body 126 material approximately at theproximal end of the graft body 126, or directly coupled to perforationsin the proximal edge region of the graft body 126. Embodiments of theconnector ring may be generally circular in shape and may have regularundulations about the circumference that may be substantially sinusoidalin shape.

The proximal self-expanding member 116 may include outwardly extendingbarbs (not shown), that may be integrally formed with the struts and mayhave sharp tissue penetrating tips configured to penetrate into tissueof an inside surface of a lumen within which the proximal self-expandingmember 116 may be deployed in an expanded state. Although the anchormembers may include proximal and distal self-expanding members 116 and117, similar expanding members may be used that are configured to beinelastically expanded with outward radial pressure as might begenerated by the expansion of an expandable balloon from within eitheror both proximal and distal self-expanding members 116 and 117. Theconnector ring coupled to the proximal self-expanding member 116 mayalso be inelastically expandable.

The distal anchor member shown in FIG. 19 includes a single distalself-expanding member 117 disposed at the distal end of the tubulargraft body 126 of the endoluminal prosthesis 110. The distalself-expanding member 117 may be formed from a resilient elongateelement having a generally serpentine shape with eight crowns or apicesat either end. A proximal end of the distal self-expanding stent member117 may be mechanically coupled to a connector ring which may beembedded in graft body 126 material of the distal end of the graft body126, or directly coupled to perforations in the distal edge region ofthe graft body 126.

A collapsible low profile fill tube 108 embodiment may aid in reducingspace within the delivery catheter 100 while in a constrained orcollapsed state such as during packaging and transportation of theendoluminal prosthesis 110 to a treatment facility. FIGS. 20-23 shows aportion of the endoluminal prosthesis 110 embodiment with the fill tubelumen 164 of the elongate shaft 152 and the fill tube 108 releasablysecured to the inflation port 106. FIG. 20 shows the elongate shaft 152,distal self-expanding member 117, and graft body 126. FIG. 21 shows apartial longitudinal section of the junction between tubular members ofthe inflation conduit 150 with a tear away portion of the fill tube 108which may be defined by a tear-away line 107 (distal self-expandingmember 117 not shown). The fill lumen 164 may be part of the multi-lumenelongate shaft 152 that houses or partially houses the catheter filltube 178 or fill tube 108. The collapsible low profile fill tube 108 maybe a flexible transition tube between the elongate shaft 152 and theinflation port 106. The fill tube 108 may be comprised of afluoropolymer, PTFE, ePTFE or combinations thereof. The PTFE of thecollapsible low profile fill tube 108 may be made out of a materialhaving a shore hardness of about 25 D to about 40 D. The PTFE of thecollapsible low profile fill tube may be made out of a sintered PTFE.The fill tube lumen 109 of the collapsible low profile fill tube 108 ina non-collapsed state may have a nominal transverse dimension of about0.5 mm to about 5 mm. The collapsible low profile fill tube 108 may havean axial length of about 5 mm to about 100 mm. Additionally, the wallthickness of the collapsible low profile fill tube may be about 0.02 mmto about 0.13 mm.

Within the elongate shaft 152, the fill tube lumen 164 contains acatheter fill tube 178 for fill material to be injected into theproximal end of the delivery catheter 100 system. The catheter fill tube178 may be a rigid tube that may contain nylon, polyimide, PTFE orsimilar material or combinations thereof. The fill tube 108 may have alarger transverse radius than the catheter fill tube 178, thuspermitting the fill tube 108 to slide over or couple to the catheterfill tube 178 to form a continuous tube such that the fill material maybe injected or pushed through the catheter fill tube 178 and into thefill tube 108. FIG. 22 shows the inflation port 106 having a largertransverse radius than the fill tube 108, permitting the inflation port106 to slide over or couple to the fill tube 108 such that the fillmaterial may be injected or pushed through the fill tube 108 and intothe inflation port 106. The collapsible low profile fill tube 108 mayhave a substantially rigid proximal end 180 configured to be releasablycoupled to an inflation port 106 of an inflatable graft body 126. Theinflation port 106 may have a substantially rigid distal end 182configured to be releasably coupled to a fill tube 108.

FIG. 23 shows the elongated shaft 152 having a larger lumen for storageof excess transitional fill tubing 108. As the delivery catheter 100 maybe moved up a patient's body into place for deployment of theendoluminal prosthesis 110, the flexible fill tube 108 may be storedwithin the multi-lumen elongate shaft 152. After the fill tube 108 maybe retracted from disjoining from the inflation port 106, the flexiblefill tube 108 may be stored within the multi-lumen elongate shaft 152.The multi-lumen elongate shaft 152 may have a fill tube cavity 165 atthe proximal end thereof which may be configured to accept a section ofthe collapsible low profile fill tube 108 that has been axiallycompressed and shortened. The fill tube cavity 165 may have asubstantially cylindrical cavity having an inner transverse dimensionconfigured to be disposed about the collapsible low profile fill tube108 in an axially compressed state. The elongate shaft 152 may have aretractable outer sheath 104 that may be disposed over the collapsiblelow profile fill tube 108 and fill tube lumen 164 of the elongate shaft152 during delivery of the endoluminal prosthesis 110 to a treatmentsite. The retractable outer sheath 104 may be configured to removablycover a constrained endoluminal prosthesis 110 disposed on the proximalsection 153 of the elongate shaft 152.

In some embodiments of the delivery catheter 100 and endoluminalprosthesis 110, there may be a multi-stage deployment embodiment ofrelease wires that constrain the proximal and distal self-expandingmembers 116 and 117 of an endoluminal prosthesis 110. Themulti-deployment embodiment involves multiple release wires with onebelt being released at a time such that the anchor member orself-expanding member release forces are reduced. Anchor member orself-expanding member release forces may be compounded due to theanatomical path an endoluminal prosthesis 110 and delivery catheter 100system navigate through. Reduction of the friction and load along thedelivery pathway may be done by incorporating a low friction surface orlumen around each release wire. Catheter element embodiments having amulti-lumen configuration, such as dual lumens or tri-lumens may providelow frictional surfaces and separate lumens for each of the releasewires to reduce stent release forces. FIG. 24 shows the proximal stent116 and distal stent 117 with proximal belt members 204, 206 and 208,proximal release wires 210 and 212, distal belt members 304, 306 and308, and distal release wires 310 and 312. FIG. 24A shows a guidewirelumen 160, a collapsed proximal self-expanding member 116 disposedaround the guidewire lumen 160, and a proximal release wire 212. FIG.24B shows a guidewire lumen 160, inflation conduit 150, a collapseddistal stent 117 around the guidewire lumen 160 and inflation conduit150, and the axial release wire 312.

FIG. 25 shows a distal section of an elongate shaft embodiment 152 anddistal actuator embodiment 400. FIG. 26 shows a schematic representationof the distal actuator 400 which houses the distal termination of theproximal release wires 210 and 212, distal release wires 310 and 312,release wire lumen 436, release wire sleeves 428, guidewire lumen 160,and multi-lumen elongate shaft 152. In the embodiments shown, the distalend of each release wire 210, 212, 310 and 312 may be secured to arespective actuator device such as an actuator cap of the actuator 400.Such actuator caps may have a nested configuration with respect to eachother. In particular, the distal end of release wire 210 is secured toactuator cap 211, the distal ends of release wires 212 and 312 are eachsecured, either directly or indirectly, to actuator cap 213, and releasewire 310 is secured to actuator cap 311. The distal end of release wire312 is indirectly secured to actuator cap 213 by a flexible tether 402which may have a length sufficient for release wire 212 to be fully orpartially actuated by actuation of actuator cap 213 before release wire312 is actuated. Also, the nesting of the actuator caps 211, 213 and 311may be configured such that the order of the release wire actuation iscontrolled by the configuration. For example, in some cases, actuatorcap 311 can not be actuated until actuator cap 213 is actuated andactuator cap 213 can not be actuated until actuator cap 211 is actuated.

FIG. 26C shows a cross section view of the elongate shaft 152 of FIG. 26illustrating a multi-lumen elongate release wire sleeve 154 with releasewires 210, 212, 310 and 312 extending through the multiple release wirelumens of the release wire sleeve 154 with each release wire having aseparate lumen in the sleeve 154. The release wires 210, 212, 310, and312, also called elongate release members, may include a proximalsection configured to releasably secure at least one respectivereleasable belt, such as proximal belt members 204, 206 and 208, anddistal belt members 304, 306 and 308. In the proximal section of thedelivery catheter 100, the proximal and distal release wires 210, 212,310 and 312 may be configured to constrain the releasable belts 204,206, 208, 304, 306 and 308. The releasable belts constrain at least oneof the proximal or distal self-expanding members 116, 117. The firstproximal release wire 210 may be configured to release its respectivereleasable belts 204 and 206 upon axial retraction of the proximalrelease wire 210 in a distal direction by a first actuation length thatmay be substantially the length the proximal release wire 210 extendsproximally beyond the junction between the proximal release wire 210 andthe releasable belts 204 and 206. The second proximal release member 212may be configured to release its respective release belt 208 upon axialretraction of the second proximal release member 212 in a distaldirection by a second actuation length 309 that may be substantially thelength the second proximal release member 212 extends proximally beyondthe junction between the proximal release member 212 and its respectiverelease belt 208. As discussed above, a flexible tether 402 may securethe distal release member or wire 312 to an actuator cap 213 of thedistal actuator 400. The flexible tether 402 includes an axial slack inits length which may be as long as or longer than the actuation lengthof the distal release member 312. As such, actuation of actuator cap 213will first actuate release wire 212 and thereafter actuate release wire312. FIGS. 26A and 26B illustrate the actuation of the proximal releasewire 212 and the distal release wire 312 with the flexible tether 402

A rotating handle embodiment 500 of a distal adapter 102 of a deliverycatheter 100 system is shown in FIG. 27. FIG. 28 is a longitudinalsection of the rotating handle embodiment 500. The rotating handleembodiment 500 may be a release mechanism disposed at the distal section151 of the elongate shaft 152 which may be in operative connection withthe proximal and distal release wires 210, 212 and 310, 312. Therotating handle 500 may enable deployment of the proximal self-expandingmember 116 or distal self-expanding member 117, allowing the user tochoose either self-expanding member 116,117 to deploy for accuracy. Therotating handle embodiment 500 may have four interlocked rings 502 onthe handle 504 which may control the actuation of their respectivebelts: proximal outer stent belt ring 506, proximal inner stent beltring 508, distal inner stent belt ring 510 and distal outer stent beltring 512. The handle 504 may be stationary and secured in fixed relationto the elongate shaft 152. The rotating actuator rings 502 may becoupled to the proximal and distal release wires 210, 212 and 310, 312and configured to axially retract the respective proximal and distalrelease wires 210, 212 and 310, 312 upon rotation of the respectiverotating ring 502 relative to the handle 504. The proximal outer stentbelt ring 506 and proximal inner stent belt ring 508 may be interlockedtogether between the rotating rings 502. Additionally, the distal innerstent belt ring 510 and the distal outer stent belt ring 512 may beinterlocked together between the rings 502. The interlocking of the beltrings can prevent accidental release of the outer belts before the innerbelt rings are released. The rotating rings actuate their respectiverelease members by a camming action. Each rotating actuator belt ringincludes an axial position on the release mechanism that generallycorresponds to an axial position of the releasable belt or belts on theproximal section of the rotating actuator ring may be configured toactuate.

The rotating handle embodiment 500 may also have a fill polymer port520, a grip 522, and a guide wire hemostatic valve 524 with a flush 526.The one or more rings 502 may rotate to pull the stent release wires210, 212 and 310, 312 generally only in one direction relative to thehandle embodiment 500. The release wires 210, 212 and 310, 312 may bespring loaded with a wire/ring released spring. Each ring 502 may have acam 530 feature with a swaged end on the associated release wire. Thering 502 may have threaded components, such as a threaded shaft 532,that translate rotation into axial release wire 210, 212 and 310, 312movement. The handle embodiment 500 design may incorporate a short throwconcept where the release wire 210, 212 and 310, 312 ends may bereleased within up to about 5 cm of the belt. The handle embodiment 500may be constructed in a variety of methods, for example, six or morepieces of the handle embodiment 500 may rotate relative to the handle504 and control the actuation of any number of release wires. The piecesmay include a threaded shaft 532, two or more cams 530, and the fourrings 502.

A grip embodiment 600 may aid a physician in retracting the outer sheath104 of a delivery catheter 100 system. During the endovascularprocedure, retraction of the sheath 104 may be difficult due to theimpacted forces of the delivery catheter 100 and slippery conditionsduring the procedure. The grip embodiment 600 may aid a physician ingripping and holding onto the delivery catheter 100. FIG. 29 illustratesan embodiment of the gripper device 600. FIG. 30 shows the gripperdevice placed on the delivery catheter 100 system. The grip 600 may havea textured, easy-to-grip surface and may be made of material thatprovides a collapsible grip, such as silicone, for example. The innersurface 602 of the grip 600 or its bore may be greater than a tubularmember to which the grip 600 may releasably couple to, such as theelongate shaft 152. Furthermore, the inner surface 602 of the grip 600may be sized such that the grip 600 may be movable relative to the, forexample, elongate shaft 152 or retractable outer sheath 104, unless thegrip 600 is squeezed. The inner surface 602 of the bore extends axiallythrough the grip 600 with an inner transverse dimension configured toslide over an outer surface of the retractable outer sheath 104 and makecontact with and frictionally grip the outer surface of the outerretractable sheath 104 when manually squeezed from an outside surface604 of the grip 600.

The inner surface 602 of the bore may be configured to have clearancebetween an inner surface 602 of the bore and an outer surface of theretractable outer sheath 104 of up to about 2 mm. Additionally, in somecases, the inner surface 602 of the bore may be configured to have noclearance between an inner surface 602 of the bore and an outer surfaceof the retractable outer sheath 104. The inner surface 602 of the boremay have a coefficient of friction of about 0.6 to about 0.95. The grip600 may have an optional axial slit or longitudinal slot 606 incommunication with the inner surface 602 of the bore which allows easyplacement onto and removal from the delivery catheter 100. Thelongitudinal slot 606 may be spread in order to allow the grip 600 to beplaced over a part of the delivery catheter 100 for lateral insertion orremoval of the outer retractable sheath 104 relative to the innersurface 602 of the bore. FIG. 31 is an elevation view in longitudinalsection of the grip 600 of FIG. 30 disposed over a distal section of theouter sheath 104 of the delivery catheter 100 system. The grip 600 mayhave an egg shaped elastomer body. The elastomer body may have a shorehardness of about 20 A to about 40 A. The elastomer body may havematerial selected from the group consisting of rubber, polyurethane,silicone and combinations thereof. The elastomer body may have a majorouter transverse dimension of about 15 mm to about 50 mm. The elastomerbody may have an axial length of about 500 mm to about 700 mm. FIG. 32is a transverse cross section view of the grip 600 of FIG. 31 takenalong lines 32-32 of FIG. 31 and illustrates the inner surface 602 ofthe bore of the grip 600. FIG. 33 is a transverse cross section view ofthe grip 600 of FIG. 31 taken along lines 33-33 of FIG. 31 andillustrates coupling of the inner surface 602 of the bore to the outersheath 104.

The entirety of each patent, patent application, publication anddocument referenced herein hereby is incorporated by reference. Citationof the above patents, patent applications, publications and documents isnot an admission that any of the foregoing is pertinent prior art, nordoes it constitute any admission as to the contents or date of thesepublications or documents.

Modifications may be made to the foregoing without departing from thebasic aspects of the embodiments discussed. Although embodiments havebeen described in substantial detail with reference to one or morespecific embodiments, those of ordinary skill in the art will recognizethat changes may be made to the embodiments specifically disclosed inthis application, yet these modifications and improvements are withinthe scope and spirit of the disclosure.

Embodiments illustratively described herein suitably may be practiced inthe absence of any element(s) not specifically disclosed herein. Thus,for example, in each instance herein any of the terms “comprising,”“consisting essentially of,” and “consisting of” may be replaced witheither of the other two terms. The terms and expressions which have beenemployed are used as terms of description and not of limitation and useof such terms and expressions do not exclude any equivalents of thefeatures shown and described or portions thereof, and variousmodifications are possible. The term “a” or “an” can refer to one of ora plurality of the elements it modifies (e.g., “a reagent” can mean oneor more reagents) unless it is contextually clear either one of theelements or more than one of the elements is described. Thus, it shouldbe understood that although embodiments have been specifically disclosedby representative embodiments and optional features, modification andvariation of the concepts herein disclosed may be resorted to by thoseskilled in the art, and such modifications and variations are consideredwithin the scope of this disclosure.

Certain embodiments are set forth in the claim(s) that follow(s).

1-7. (canceled)
 8. A delivery system for delivery of an endoluminalprosthesis, comprising: an elongate shaft with sufficient columnstrength for percutaneous advancement within a patient's body lumen, theelongate shaft including a proximal section and a lumen extendingtherein; an endoluminal prosthesis disposed on the proximal section ofthe elongate shaft, said prosthesis comprising a tubular body portiondefining a body lumen extending therein; at least one releasable beltdisposed on the endoluminal prosthesis and configured to releasablyconstrain at least a portion of said endoluminal prosthesis; at leastone elongate release member in communication with a distal end of theelongate shaft and including a proximal section configured to releasablysecure at least one releasable belt while said releasable belt is in aconfiguration that constrains at least a portion of the endoluminalprosthesis; and an elongate release wire sleeve disposed within andextending through at least a portion of the prosthesis body lumen. 9.The delivery system of claim 8 wherein the release wire sleeve isdisposed within and extending through at least a portion of the elongateshaft lumen.
 10. The delivery system of claim 9 wherein the sleeveextends from a distal section to the proximal section of the elongateshaft.
 11. The delivery system of claim 8, comprising a plurality ofbelts configured to releasably constrain the prosthesis.
 12. Thedelivery system of claim 11, comprising a plurality of release membersconfigured to releasably secure at least one respective releasable beltwhile said releasable belt constrains at least a portion of anendoluminal prosthesis.
 13. The delivery system of claim 12, comprisinga separate lumen for each of the plurality of release members.
 14. Thedelivery system of claim 8, wherein the prosthesis comprises aself-expanding member secured to the proximal end of the tubular bodyportion.
 15. The delivery system of claim 14, wherein a releasable beltis disposed on the endoluminal prosthesis and configured to releasablyconstrain a portion of the self-expanding member.
 16. The deliverysystem of claim 11, wherein the plurality of releasable belts aredisposed on the endoluminal prosthesis and configured to releasablyconstrain portions of the self-expanding member.
 17. The delivery systemof claim 8, wherein the at least one elongate release member comprisesan elongate release wire.
 18. The delivery system of claim 8, whereinthe elongate shaft comprises an elongate multi-lumen member extendingfrom a distal section of the elongate shaft to a proximal section of theelongate shaft, the multi-lumen member comprising a guidewire lumen anda lumen within which the release wire sleeve is disposed.
 19. Thedelivery system of claim 8, comprising a retractable outer sheathdisposed over the elongate release wire sleeve and removably coveringthe prosthesis in a constrained configuration.
 20. The delivery systemof claim 8, wherein the prosthesis comprises a tubular graft body. 21.The delivery system of claim 20, wherein at least one release wiresleeve is disposed within and extending through entire length of thegraft body lumen.
 22. The delivery system of claim 8, wherein theelongate release wire sleeve comprises a low friction material.